This position will be responsible primarily for distribution of clinical drug supplies, API, and other related supplies in support of Biotie’s drug development programs and domestic/international clinical studies. The position should provide expertise in the areas of clinical packaging design, clinical packaging and labeling, domestic and international shipment of drug products from CMOs to packaging/labeling facilities and from packaging/labeling facilities to clinical sites and depots, vendor management at domestic and international packaging/labeling facilities, oversight of packaging/labeling operations (including review/approval of master and executed records) and, if applicable, blinding operations. This position will interact closely with the Clinical Operations, Regulatory, QA, and CMC departments to assure that the CMC quality systems related to clinical supplies management meet international regulatory compliance requirements. Other activities include assisting clinical operations on items such as packaging design, IVRS vendor selection, and other activities as needed. This person will also take on other activities as needed in the CMC area, such as oversight of all company international shipping operations for drug substances, drug products, and other associated raw materials (including cold chain management), assist in preparing IND and NDA-related documentation, and budget planning and monitoring for the Clinical Supply Management function. The individual must possess excellent communication, writing, and negotiation skills and the ability to work with cross-functional project team members and development partners, while providing strategic guidance to project teams in a dynamic environment. The position currently reports to the Sr. Director, CMC Operations.
- Coordinate the design and approval of vendor work proposals, labels, packaging, and batch records
- Function as the primary contact for packaging/labeling distribution vendors
- Provide shipping requirements (e.g., temperature sensitive, temp monitor, pre-qualified shipper, ambient shipper, etc.) and review/approve distribution protocols
- Work with QA to facilitate clinical product release and management of shipping deviations. Track usage and inventory.
- Promptly identify and escalate risks to study supply to all key stakeholders
- Strategize with study managers and review clinical study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans
- Promptly communicate changes in study demand to Manufacturing team
Skills and Experience Required:
- BA/BS or higher degree in a pharmaceutically-related field with a minimum of 5 years broad experience with clinical supply management and distribution, including managing supplies for blinded and large-scale Phase 3 clinical trials
- Comprehensive understanding of all supply chain dynamics, processes, and workflow
- Excellent interpersonal, verbal and written communication skills
- Demonstrated proficiency with Microsoft Office and Microsoft Project
- Ability to manage multiple projects and priorities simultaneously, with strong data analysis, problem solving, decision-making skills, and leadership ability in team settings
- Ability to travel to contract sites worldwide
Biotie is a specialized drug development company focused on products for neurodegenerative and psychiatric disorders. For the past years,...